Immune Pharmaceuticals Announces Phase 3 Development and Commercialization Strategy for AMIKET
05 Mai 2014 - 8:30AM
Immune Pharmaceuticals Inc. (OTCQX: IMNP) (Nasdaq:IMNP) ("Immune"
or the "Company") announces its clinical trial and
commercialization strategy for AmiKet, a topical drug for the
treatment of Neuropathic Pain, pursuant to which the Company is
ready to advance to phase 3 clinical trials, based on nine clinical
trials in a total of 1700 patients. AmiKet is a topical
combination of amitryptiline and ketamine designed
to reduce the pain of patients with Post Herpetic Neuralgia
(PHN), Diabetic Peripheral Neuropathy (DPN) and Chemotherapy
Induced Neuropathic Pain (CIPN).
Following a clinical, regulatory and commercial assessment,
Immune will prioritize Post Herpetic Neuralgia (PHN) as its first
indication for the development and commercialization of AmiKet.
AmiKet has received Orphan Drug Designation for PHN and completed
successfully three phase 2 PHN trials. In the first trial, AmiKet
demonstrated statistically significant efficacy in reducing pain in
PHN patients in both low and high dose versus placebo. A second
clinical trial rank ordered AmiKet as superior to each of its
drug component and placebo. In a third clinical trial, AmiKet
demonstrated statistically significant non-inferiority to high dose
oral gabapentin, one of the most frequently used drug for
Neuropathic Pain.
Dr. Daniel Teper, Chairman and CEO of Immune stated: "We are
preparing a Phase 3 plan with PHN as a lead indication and will
continue to seek pain specialist development and
commercialization partners on a regional or global level."
Dr. Elliott Goldstein, Chief Medical Officer of Immune,
commented: "There is an outstanding medical need for
patients suffering with Neuropathic Pain, with no single
drug achieving more than a 50% responder rate, accompanied
by the unsatisfactory tolerability of
oral therapies. Market research suggests a strong interest and
preference of both physicians and patients for topical
treatments."
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. applies a personalized approach to
treatment, developing novel, highly targeted antibody therapeutics
to improve the lives of patients with inflammatory diseases and
cancer. The Company's lead product candidate, bertilimumab, is
in clinical development for moderate to severe ulcerative
colitis and Crohn's Disease as well as bullous pemphigoid, an
orphan auto-immune dermatological condition, Immune licensed
worldwide rights for systemic indications of bertilimumab from iCo
Therapeutics (TSX-V:ICO) (OTCQX:ICOTF) in June 2011, while iCo
retained rights to all ophthalmic indications. iCo originally
licensed the exclusive world-wide rights to bertilimumab in 2006
from MedImmune, the Global Research and Development Arm of
AstraZeneca. Immune's pipeline also includes NanomAbs®,
antibody nanoparticle conjugates, for the targeted delivery of
chemotherapeutics., Crolibulin, a small molecule in Phase II in
collaboration with the National Cancer Institute and Amiket™, a
Neuropathic Pain drug candidate ready for Phase III. Amiket has
received Orphan Drug Designation for Post Herpetic Neuralgia.
For more information, visit Immune's website at
www.immunepharmaceuticals.com, the content of which is not a part
of this press release.
Erik Penser Bankaktiebolag is engaged as Immune's Certified
Adviser on NASDAQ OMX First North Premier.
Forward-Looking Statements
This news release and any oral statements made with respect to
the information contained in this news release contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal" or the negative of those words or
other comparable words to be uncertain and forward-looking. Such
forward-looking statements include statements that express plans,
anticipation, intent, contingency, goals, targets, future
development and are otherwise not statements of historical fact.
These statements are based on our current expectations and are
subject to risks and uncertainties that could cause actual results
or developments to be materially different from historical results
or from any future results expressed or implied by such
forward-looking statements. Factors that may cause actual results
or developments to differ materially include, but not limited to:
the risks associated with the adequacy of our existing cash
resources and our ability to continue as a going concern; the risks
associated with our ability to continue to meet our obligations
under our existing debt agreements; the risk that we will not be
able to find a partner to help conduct the Phase 3 trials for
AmiKet™ on attractive terms, a timely basis or at all the risk that
we will not obtain approval to market and commercialize any of our
product candidates; the risks associated with dependence upon key
personnel; the risks associated with reliance on collaborative
partners and others for further clinical trials, development,
manufacturing and commercialization of our product candidates; the
cost, delays and uncertainties associated with our scientific
research, product development, clinical trials and regulatory
approval process; our history of operating losses since our
inception; the highly competitive nature of our business; risks
associated with litigation; risks associated with our ability to
protect our intellectual property; risks associate with our ability
to raise additional funds; and our liquidity. These factors and
other material risks are more fully discussed in our periodic
reports, including our reports on Forms 8-K, 10-Q and 10-K and
other filings with the U.S. Securities and Exchange Commission. You
are urged to carefully review and consider the disclosures found in
our filings which are available at www.sec.gov or at
www.immunepharmaceuticals.com. You are cautioned not to place undue
reliance on any forward-looking statements, any of which could turn
out to be wrong due to inaccurate assumptions, unknown risks or
uncertainties or other risk factors. We expressly disclaim any
obligation to publicly update any forward-looking statements
contained herein, whether as a result of new information, future
events or otherwise, except as required by law.
CONTACT: Immune Pharmaceuticals Inc.:
708 Third Avenue, Suite 210
New York, NY 10017
Anna Baran, Director of Investor Relations
and Corporate Communications
Tel: (646) 937-1941
anna.baran@immunepharma.com
Immune Pharmaceuticals Ltd.:
11C Galgale HaPlada
Herzliya-Pituach, Israel 46733
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