Immune Initiates Bertilimumab Phase II Clinical Trial in Ulcerative Colitis

  Immune Initiates Bertilimumab Phase II Clinical Trial in Ulcerative Colitis

   Bertilimumab Targets Eotaxin-1, a Chemokine Over-Expressed in Ulcerative
                               Colitis Patients

Business Wire

HERZLIYA-PITUACH, Israel & TARRYTOWN, N.Y. -- February 21, 2013

Regulatory News:

Immune Pharmaceuticals Ltd. (“Immune”), a privately held Israeli company, and
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced
today that Immune is initiating, following authorization from Israeli health
authorities, a Phase II double-blind placebo controlled study with its lead
drug, bertilimumab, in patients with moderate-to-severe ulcerative colitis.
Bertilimumab is a first-in-class fully human monoclonal antibody targeting
eotaxin-1, a chemokine small protein regulating eosinophilic inflammation.

The clinical trial is a randomized, double-blind, placebo-controlled parallel
group study that will evaluate the safety, clinical efficacy, and
pharmacokinetic profile of bertilimumab in subjects with active
moderate-to-severe ulcerative colitis. 90 patients are expected to be enrolled
into the study, 60 of whom will be treated with bertilimumab 7mg/kg and 30 of
whom will be treated with placebo every two weeks, at days 0, 14, and 28.
These patients will be evaluated for clinical response after six weeks to
determine the decrease if any in the full Mayo Clinic Ulcerative Colitis
Score. Secondary and exploratory end points will include clinical remission
defined as symptom free, fecal calprotectin, a recognized marker of
gastro-intestinal inflammation, histopathology improvement and degree of
mucosal injury. Patient follow-up will continue up to day 90. Patients will be
enrolled initially from up to 10 hospitals in Israel and later in other
countries pending approval of local health authorities. Completion of patient
enrollment and clinical results are anticipated in 2014.

Professor Eran Goldin, lead investigator for the clinical trial and Director
of the Digestive Disease Institute at Shaare Tsedek Hospital in Jerusalem,
Israel, stated, “Eotaxin-1 is a novel target which has been validated through
extensive pre-clinical and observational clinical studies. The upcoming Phase
II study with bertilimumab has been designed to assess the clinical relevance
of neutralizing eotaxin-1 in patients with active moderate-to-severe
ulcerative colitis.”

Daniel Teper, Pharm. D., CEO of Immune and Stephane Allard, M.D., Chief
Medical Officer of EpiCept and designated Chief Medical Officer of the
combined company following completion of the proposed merger between EpiCept
and Immune, commented, “There is a clear need for alternative biological
therapies for patients with ulcerative colitis. The established correlation
between eotaxin-1 levels in tissue and the severity of the disease provides an
opportunity to select patients most likely to respond to therapy.”

Immune and EpiCept signed a definitive agreement to merge on November 7, 2012
and currently anticipate a closing of the transaction in the second quarter of
2013. Bertilimumab will be the lead clinical stage development drug for the
combined company following completion of the proposed merger.

About Bertilimumab

Bertilimumab (also known as iCo-008 or CAT-213) is a human immunoglobulin
monoclonal antibody targeting eotaxin-1, a member of the chemokine family of
proteins that act as messenger molecules between the cells of the immune
system. Bertilimumab has been the subject of several Phase 1 and 2 studies
involving a total of 126 patients in the United Kingdom, has a good safety
profile and has shown evidence of biological efficacy in single dose
administration. Bertilimumab may be indicated for inflammatory disorders
including inflammatory bowel disease (Crohn's Disease and ulcerative colitis),
severe asthma, and orphan dermatological conditions such as bullous

iCo Therapeutics (TSX: ICO) licensed the exclusive world-wide rights to
bertilimumab in 2006 from Cambridge Antibody Technology Limited, now part of
MedImmune, the global biologics research and development arm of AstraZeneca.
iCo has retained the rights to develop the ophthalmic indications of
bertilimumab including severe ocular allergies (vernal & atopic
keratoconjunctivitis) and wet-age related macular degeneration.

About the Immune Epicept Merger

In November 2012, Immune and EpiCept announce that they had entered into a
definitive merger agreement. The transaction is currently anticipated to close
during the second quarter of 2013 and is subject to satisfaction of certain
customary closing conditions, including the approval of a majority of EpiCept

Additional Information

In connection with the proposed transaction, EpiCept will file a proxy
statement with the U.S. Securities and Exchange Commission (SEC) seeking
appropriate stockholder approval. STOCKHOLDERS OF EPICEPT AND OTHER INVESTORS
stockholders will be able to obtain a copy of the proxy statement, as well as
other filings containing information about Immune and EpiCept, without charge,
at the SEC's Internet site ( Copies of the proxy statement and
the filings with the SEC that will be incorporated by reference in the proxy
statement can also be obtained, without charge, by directing a request to
EpiCept Corporation, 777 Old Saw Mill River Rd, Tarrytown, NY 10591,
Attention: Investor Relations, Telephone: (914) 606-3500.

Participants in the Solicitation

EpiCept and its directors and executive officers and Immune and its directors
and executive officers may be deemed to be participants in the solicitation of
proxies from the stockholders of EpiCept in connection with the proposed
transaction. Information regarding the special interests of these directors
and executive officers in the merger transaction will be included in the proxy
statement of EpiCept referred to above. Additional information regarding the
directors and executive officers of EpiCept is also included in EpiCept's
proxy statement for its 2011 Annual Meeting of Stockholders, which was filed
with the SEC on April 28, 2011. Additional information regarding the directors
and executive officers of EpiCept is also included in EpiCept's registration
statement Post-Effective Amendment No. 1 to Form S-3 on Form S-1, which was
filed with the SEC on April 6, 2012. These documents are available free of
charge at the SEC's web site (  and from Investor Relations at
EpiCept at the address described above.

This communication shall not constitute an offer to sell or the solicitation
of an offer to buy any securities, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities laws of
any such jurisdiction. No offering of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the Securities Act
of 1933, as amended (the "Act"). The securities issued in exchange for all of
the outstanding shares of Immune will not be and have not been registered
under the Act and may not be offered or sold in the United States absent
registration or an applicable exception from registration requirements.

The merger agreement and any accompanying issuance of shares by Immune
Pharmaceuticals are not, under any circumstances, to be construed as an
advertisement or a public offering of securities in Israel. Any public offer
or sale of securities in Israel may be made only in accordance with the
Israeli Securities Act-1968 (which requires, inter alia, the filing of a
prospectus in Israel or an exemption therefrom).

About Immune Pharmaceuticals Ltd.

Immune Pharmaceuticals Ltd. is an Israel and U.S.-based biopharmaceutical
company, focused on the development of next generation antibody therapeutics
addressing unmet medical needs in the treatment of inflammatory diseases and
cancer. Immune licensed worldwide rights for systemic indications of
bertilimumab from iCo Therapeutics (TSX: ICO) in June 2011, while iCo retained
rights to all ophthalmic indications. iCo originally licensed the exclusive
world-wide rights to bertilimumab in 2006 from Cambridge Antibody Technology
Limited, now part of MedImmune, the global biologics research and development
arm of AstraZeneca. Additionally, Immune has licensed from Yissum, the
technology transfer company of the Hebrew University of Jerusalem, the
injectable applications of the antibody nanoparticle conjugate technology
(NanomAbs®) developed by Professor Shimon Benita. For more information, visit
the Immune website at:

About EpiCept Corporation

EpiCept is focused on the development and commercialization of pharmaceutical
products for the treatment of pain and cancer. The Company's pain portfolio
includes AmiKet™, a prescription topical analgesic cream in late-stage
clinical development designed to provide effective long-term relief of pain
associated with peripheral neuropathies. The Company's product Ceplene^®, when
used concomitantly with low-dose IL-2, is intended as remission maintenance
therapy in the treatment of AML for adult patients who are in their first
complete remission. The Company sold all of its rights to Ceplene^® in Europe
and certain Pacific Rim countries and a portion of its remaining Ceplene^®
inventory to Meda AB in June 2012. Ceplene^® is licensed to MegaPharm Ltd. to
market and sell in Israel and EpiCept has retained rights to Ceplene^® in all
other countries, including countries in North and South America. The Company
has other oncology drug candidates in clinical development that were
discovered using in-house technology and have been shown to act as vascular
disruption agents in a variety of solid tumors.

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 which 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: the risk
that we may be unable to complete the proposed merger transaction, the risks
associated with the adequacy of our existing cash resources and our ability to
continue as a going concern, the risks associated with EpiCept’s ability to
continue to meet its obligations under its existing debt agreements, the risk
that we will not be able to find a partner to help conduct the Phase III
trials for AmiKet™ on attractive terms, a timely basis or at all, the risk
that our product candidates that appeared promising in early research and
clinical trials do not demonstrate safety and/or efficacy in larger-scale or
later-stage clinical trials, the risk that we will not obtain approval to
market 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; and risks associated with our ability to
protect our intellectual property. These factors and other material risks are
more fully discussed in EpiCept’s periodic reports, including 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 EpiCept’s filings which are available at or at 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.


Immune Pharmaceuticals:
New York Office:
Anna Baran, 646-937-1941
Director of Corp. Development
EpiCept Corporation:
Robert W. Cook, CEO, 914-606-3500
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